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Ultrasound Assessment of the Adventitia, Extra-media (EMT) and Veia Jugularis Interna Thickness

Ultrasound Assessment of the Adventitia, Extra-media (EMT) and Veia Jugularis Interna Thickness in Obese Subjects Following a Significant Weight Loss

Lead sponsor

Henrik Gudbergsen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

80

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

BMI ≥27

Primary endpoint

The mean thickness of adventitia, extra-media thickness (EMT)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03208881
Org study ID137.10

Timeline

Milestones

Study first posted2017-07-06actual
Study start2017-07-15actual
Last update posted2018-11-27actual
Primary completion2019-01estimated (month precision)
Study completion2019-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years
Maximum age74 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

Inclusion criteria

Informed consent obtained
Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
Age ≥ 18 years and < 75 years
Body mass index (BMI) ≥ 27 kg/m2
Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
Motivated for weight loss

Exclusion criteria

On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
Type 1 diabetes
Type 2 diabetes treated with glucose-lowering drugs other than metformin
Alloplasty in target knee joint (see section 6.3)
End stage disease in target knee joint (Kellgren-Lawrence grade 4)
Immuno-inflammatory disease
Chronic wide-spread pain
Pregnancy or insufficient anti-conception therapy for female fertile patients
Breast-feeding
Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
Surgery scheduled for the trial duration period, except for minor surgical procedures
Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Inflammatory bowel disease
Congestive heart failure, New York Heart Association (NYHA) class III-IV
Diabetic gastroparesis
History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
Inability to speak Danish fluently
A mental state impeding compliance with the program
Use of opioids or similar strong analgesics
Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Cardiometabolic biomarkers

4 endpoints
Primary/protocol endpoint/low confidence

Change in the mean thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

Time frame:Week -8 to 0

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in the maximal thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

Time frame:Week -8 to 0

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Long-term change in the mean thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

Time frame:Week 0 to 52

change from baseline, improvement

Secondary/protocol endpoint

Long-term change in the maximal thickness of adventitia, extra-media thickness (EMT), and vena jugularis interna assessed in mm

Time frame:Week 0 to 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.